Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Thursday, November 19, 2015

What Revolving Door? - An Unprecedented Endorsement of a Political Appointment by the "Gold Standard" Medical Journal

An Unprecedented Endorsement

It's deja vu all over again. In the spring of 2015, the New England Journal, the most prestigious US medical journal, published a remarkable series of opinion pieces extrolling physician-industry collaborations, and minimizing the significance of resulting conflicts of interest. More remarkable was the extent that the articles' argument were bolstered by logical fallacies (look here).

Doubling down, the New England Journal of Medicine appeared to make its first ever endorsement of a nominee for federal office. On October 28, 2015, the NEJM published an editorial with the almost campaign slogan like title, "Califf for the FDA," which enthusiastically endorsed the current presidential nominee to be Commissioner of the US Food and Drug Administration (FDA). (1) It began, [with italics added for emphasis]

Robert M. Califf, M.D., has been nominated to be the next head of the
Food and Drug Administration (FDA); he currently serves as Deputy
Commissioner for the Office of Medical Products and Tobacco. We think
his confirmation as commissioner should proceed as quickly as possible.
Because the FDA oversees the safety and, in some spheres, the efficacy
of products that constitute about 25% of our economy, the country needs a
strong and experienced leader who can keep the FDA focused on its
mission.

And the editorial concluded,

Califf's experience, his proven leadership abilities, his record of
robust research to guide clinical practice, and his unwavering
dedication to improving patient outcomes are unsurpased qualifications
for the post of commissioner of the FDA; we strongly endorse his
nomination and urge the Senate to act favorably on it.

I have never seen this journal, known primarily for publishing
research and scholarly opinion on medicine and health care, publicly
render an opinion about a nomination for a federal position, let alone such an enthusiastic one. A quick
search of the journal revealed that it had taken no position and made no
comment about the nominations of the last three US FDA Commissioners, (Dr Margaret
Hamburg, Dr Andrew von Eschenbach, Dr Lester Crawford, and Dr Mark
McClellan, look here) who were nominated by one Democratic and one Republican President.

Dismissing Concerns about Conflicts of Interest

This fervid endorsement came in the face of some controversy about the nomination, particularly about Dr Califf's previous ties to industry (see this post ). He has participated in many industry sponsored clinical research projects. For example, a 2013 JAMA disclosure statement included 13 commercial research sponsors of his work. It also noted his consultative relationships with 32 commercial firms. We discovered he also had a "board level" conflict of interest, having been a director of Portola Pharmaceuticals, for which he received over $250,000 in 2014 (see this proxy statement). He also had been paid for "educational activities" in previous years, possibly including "drug talks," at least per one blogger. So in my humble opinion, the nomination of Dr Califf could potentially become one of the most significant health care revolving door cases to affect US government.

Such consideration may have influenced Senator Bernie Sanders (I - Vermont), who is currently running for President. In early October he announced he would oppose the Califf nomination.

Furthermore, since our post but before the publication of the NEJM editorial, there have been new revelations. Dr Califf twithdrew as authors from several papers that had been accepted for publication, seemingly violating norms for declaring authorship of scholarly works, (see the Boston Globe here). Dr Califf was revealed to have been a
board member of and consultant to Faculty Connection LLC, which advises
academic researchers "who want to work with industry" about regulatory
submissions (see Intercept.com here)

Yet the Editor of the New England Journal of Medicine dismissed concerns about Dr Califf's industry relationships,

a few concerns have been expressed about his associations with industry, and these concerns may have caused some to withhold support for his nomination.

Like Califf, we believe that our actions should be driven by data, not innuendo. Since 2005, Califf has reported, as an investigator, the outcomes of seven clinical trials sponsored solely by industry in primary publications in major general medical journals. Of these trials, four had a negative outcome (i.e., not favoring the intervention), two favored the intervention, and one, with a factorial design, had a mixed outcome. Given this performance, it is impossible to argue that Califf has a pro-industry bias.

Dr
Robert M Califf ... coasted through a confirmation hearing on Tuesday,
with most members of a Senate committee - including some who have been
skeptical about his ties to the pharmaceutical industry - seeming set to
support his candidacy.

This occurred despite one more major revelation that appeared since the editorial was published, but before the hearing. A large pharmaceutical company clinical trial which Dr Califf ran had been criticized as biased in favor of the company's drug by the FDA's own staff and consultants. (see POGO here). And it occurred despite calls by various organizations for the nomination to be turned down, including by Public Citizen and the AIDS Healthcare Foundation (see Medscape here).

Missing the Main Point

However, the NEJM editorial seemed to miss the main point. It revolved around the claim that

It is impossible to argue that Califf has a pro-industry bias.

This was based apparently on an informal evaluation by Dr Drazen of seven of Dr Califf's 1200 publications. So at best this was about the question of pro-industry bias in
research publications.

However, the controversy is about Dr Califf's nomination as the head of the US government agency that oversees the pharmaceutical, device and biotechnology industries, among others, and tries to assure the safety and effectiveness of drugs, biologics and medical devices, among other responsibilities. The overriding issue is about the risk that his decision making in these capacities could be biased. The real issue is the revolving door, not bias in research.

As we have repeated very recently, the revolving door can be veiwed as a species of conflict of interest. Government officials who can look forward to extremely lucrative
employment in health care industry may be much more
inclined to seem friendly to the industry while in office. Government
officials who were previously paid by industry, and who benefited from
financial interactions with industry, are likely to maintain their
industry mindset and be mindful of their industry friends. But the
concern here is not that this risks biasing future research. The risk
is that a person who previously enjoyed close ties, including close
financial ties to industry is at risk of putting the interests of
industry over those of citizens and patients while running a US
government agency charged with regulating that industry and protecting
the health and safety of those citizens and patients.

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Dr Drazen's editorial never directly addressed that issue. It is one that should still be a concern.

Mission-Hostile Management?

Finally, the effect of the Califf nomination on the FDA has generated considerable public comment. The effect of the New England Journal of Medicine's unprecendented editorial endorsement of the nomination has generated almost no discussion. Only on the 1BoringOldMan blog was there note of the past industry ties of the current NEJM editor inspired their own controversies, and asked "since when is the editorship of the NEJM a position from which to weigh in on such matters?" (look here).

Using the editorship to so weigh in could not only obfuscate the debate about the nomination. It could threaten the mission of a proud medical institution. The NEJM claims a

reputation as the 'gold standard' for quality biomedical research and for the best practices in clinical medicine.

thoughtful, carefully reasoned analyses and interpretations [which] help
you crystallize your own opinions on current topics and findings

Yet the blanket and unprecedented endorsement of the current FDA nominee appears otherwise. We have previously argued that the earlier NEJM opinion pieces on conflicts of interest were based on logical fallacies more than "thoughtful, carefully reasoned analyses and interpretation." In the Editor's apparent haste to defend industry-physician relationships, he risks the reputation and mission of once what was really a gold standard.

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